Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00603824
Recruitment Status : Withdrawn (PI relocated)
First Posted : January 29, 2008
Last Update Posted : September 13, 2016
University of Tennessee
Information provided by:
Methodist Healthcare

Brief Summary:
The purpose of this study is to test the safety and efficacy of fondaparinux in patients with heparin-induced thrombocytopenia (HIT). The primary objective is to ensure that patients with HIT who are treated with fondaparinux experience a prompt and complete recovery of their platelet count, and the secondary objective is to determine if any new blood clots are formed while receiving the fondaparinux and up to one month after study enrollment. This information will be compared to a historical control.

Condition or disease Intervention/treatment Phase
Heparin-Induced Thrombocytopenia Drug: fondaparinux Drug: argatroban or lepirudin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia
Study Start Date : January 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Experimental: A
Drug: fondaparinux
fondaparinux subcutaneous injection once daily until INR stable in therapeutic range, at least five days: 5 mg if less than 50 kg, 7.5 mg if 50-100 kg, 10 mg if >100 kg
Other Name: Arixtra

Active Comparator: B
Direct thrombin inhibitor
Drug: argatroban or lepirudin
continuous infusion titrated into therapeutic range and for at least 5 days and until INR stable in therapeutic range
Other Name: Refludan

Primary Outcome Measures :
  1. Platelet count recovery [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Recurrent thromboembolic complications [ Time Frame: 4 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female at least 18 years of age;
  • If female of childbearing potential, negative pregnancy test result;
  • Diagnosis of HIT confirmed by the following: Decreased platelet count by 50% or greater OR platelets < 100,000/mm3 during or within 2 weeks after heparin exposure and/or new thromboembolic complications during or within 2 weeks after heparin exposure;
  • Laboratory confirmation (either heparin PF4 antibody or serotonin release assay positive).

Exclusion Criteria:

  • Estimated creatinine clearance less than 30 ml/min (either measured or by using Cockcroft Gault equation);
  • Pregnancy or lactating;
  • Blood dyscrasia other than HIT;
  • History of thrombocytopenia associated with fondaparinux;
  • Recent (within 6 weeks) or planned surgery of CNS, eye or traumatic surgery resulting in large open surfaces or other procedures with high bleeding risk or if lumbar puncture is planned;
  • Active bleeding of GI tract, GU tract, CNS or respiratory tract;
  • Malignant hypertension, pericarditis, pericardial effusion, endocarditis or eclampsia;
  • Inadequate laboratory facilities, inadequate support system at home, alcoholism, drug abuse, psychosis or dementia;
  • Hypersensitivity or contraindication to warfarin or fondaparinux.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00603824

Sponsors and Collaborators
Methodist Healthcare
University of Tennessee
Principal Investigator: Bob L Lobo, Pharm.D. Methodist University Hospital
Principal Investigator: Sohail Minhas, MD University of Tennessee

Responsible Party: Bob Lobo, Program Director, Clinical Pharmacy, Vanderbilt University Identifier: NCT00603824     History of Changes
Other Study ID Numbers: MHIRB # 2007-058
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: June 2009

Keywords provided by Methodist Healthcare:
heparin-Induced thrombocytopenia

Additional relevant MeSH terms:
Blood Platelet Disorders
Hematologic Diseases
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors